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Invivyd | 8-K: Current report

SEC announcement ·  Jan 3 00:00
Summary by Moomoo AI
On January 3, 2024, Invivyd, Inc., a biopharmaceutical company, announced the submission of a request for Emergency Use Authorization (EUA) to the U.S. Food and Drug Administration (FDA) for its monoclonal antibody candidate, VYD222, aimed at the pre-exposure prevention of COVID-19 in immunocompromised adults and adolescents. The EUA request is supported by positive initial results from the ongoing CANOPY Phase 3 pivotal clinical trial and in vitro neutralization activity against current SARS-CoV-2 variants, including the rapidly spreading JN.1 variant. Invivyd's CEO, Dave Hering, expressed confidence in VYD222's continued neutralization activity and the company's strategic approach to targeting conserved epitopes to keep pace with viral evolution. The company is also preparing for a potential commercial launch of VYD222, should the EUA...Show More
On January 3, 2024, Invivyd, Inc., a biopharmaceutical company, announced the submission of a request for Emergency Use Authorization (EUA) to the U.S. Food and Drug Administration (FDA) for its monoclonal antibody candidate, VYD222, aimed at the pre-exposure prevention of COVID-19 in immunocompromised adults and adolescents. The EUA request is supported by positive initial results from the ongoing CANOPY Phase 3 pivotal clinical trial and in vitro neutralization activity against current SARS-CoV-2 variants, including the rapidly spreading JN.1 variant. Invivyd's CEO, Dave Hering, expressed confidence in VYD222's continued neutralization activity and the company's strategic approach to targeting conserved epitopes to keep pace with viral evolution. The company is also preparing for a potential commercial launch of VYD222, should the EUA be granted. The CANOPY trial, which completed enrollment in November 2023, is evaluating VYD222's efficacy in preventing symptomatic COVID-19 and has shown promising early signs of clinical protection and a favorable safety profile. VYD222 has demonstrated in vitro potency against various SARS-CoV-2 variants, and if authorized, Invivyd plans to make it commercially available shortly thereafter.

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